Kornimate/medical-research-clean huggingface dataset:
proof of concept study to evaluate the efficacy and safety of bms-931699 (lulizumab) or bms-986142 in primary sjögren's syndrome

Conditions: Sjögren's Syndrome

Summary: the primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or bms-986142 versus placebo in subjects with moderate to severe primary sjögren's syndrome as measured by the change from baseline in essdai at week 12 between active treatment arms (lulizumab or bms-986142, respectively) and the placebo arm.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects diagnosed or classified as having moderate to severe primary sjögren's syndrome based on the 2016 acr-eular sjögren's syndrome classification criteria for at least 16 weeks prior to screening * essdai ≥ 5 including disease activity (any score \> 0) in at least one of the following domains: glandular, articular, hematological, biological, lymphadenopathy * positive anti-ss-a/ro and/or anti-ss-b/la autoantibody * unstimulated whole saliva secretion \> 0.01 ml/min * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. hormone-based contraceptive methods are not permitted exclusion criteria: * secondary sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, ra, sle, multiple sclerosis, vasculitis) * very severe primary sjögren's syndrome or severe complications of primary sjögren's syndrome at the time of the screening visit * active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic hepatitis b or c infection, or hiv infection * any significant concurrent medical condition at the time of screening or baseline visit * use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (mmf) or leflunomide within 12 weeks of screening visit * previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit * treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit * oral corticosteroids \> 10 mg/day within 14 days of dosing (day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit other protocol defined inclusion/exclusion criteria could apply
study on treatment of varicose veins by endovenous laser (1940 nm vs 1470 nm)

Conditions: Varicose Veins

Summary: the goal of this clinical trial is to compare efficacy of two wavelength for endovenous laser ablation (evla) in treatment of varicose veins of the lower limbs. the main questions it aims to answers are : 1. is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ? 2. is the increase of wavelength reduce complication or pain ? participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation. after laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation. researchers will compare strategy 1(evla with an endovenous laser at 1940 nm) vs strategy 2 (evla with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of evla treatment can be reduced.


Eligibility criteria:
inclusion criteria: * primary insufficiency of the great saphenous vein (gsv) and/or small saphenous vein (ssv) * patient candidate for endothermic treatment of the lower limbs * ceap: c2 - c6 * patient with a target vein diameter (gsv and/or ssv) \>= 3 mm throughout the target vein segment * patient affiliated or beneficiary of a social security scheme * patient having signed the informed consent exclusion criteria: * patient with a current serious pathology and/or a life expectancy of less than 5 years * patient who has had a deep or superficial vein thrombosis in the previous 6 months * obliterating arteriopathy of the lower limb concerned, with an ips \ 1.3 * patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb * patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb * suspicion of non-post-thrombotic iliac compression on echo-doppler * contraindication to the planned treatment technique * patient whose geographical distance is not compatible with the follow-up of the study * pregnant or breastfeeding women * patient linguistically or psychologically unable to understand the information given, to give informed consent or to answer the study questionnaires. * protected patients: adults under guardianship, or other legal protection; hospitalized without consent.

Keywords: endovenous laser ablation (evla)
99mtc-darping3 spect/ct for non-invasive her2-ax in breast cancer with metastatic lymph nodes before targeted therapy

Conditions: Breast Cancer Female

Summary: an open-label, single center study with 99mtc-darping3 spect/ct and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the her2 expression measured by 99mtc-darping3 spect/ct and standard histopathology from relevant tumor and lymph node biopsies.

overall goal of the project: to determine her2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.

Eligibility criteria:
inclusion criteria: * subject is \> 18 years of age * diagnosis of primary breast cancer with lymph node metastases * availability of results from her2 status previously determined on material from the primary tumor and metastatic ln, either a. her2-positive, defined as a dako herceptest™ score of 3+ or fish positive or b. her2-negative, defined as a dako herceptest™ score of 0 or 1+; or else if 2+ then fish negative * hematological, liver and renal function test results within the following limits: white blood cell count: \> 2.0 x 109/l; hemoglobin: \> 80 g/l; platelets: \> 50.0 x 109/l; alt, alp, ast: =\< 5.0 times upper limit of normal; bilirubin =\< 2.0 times upper limit of normal; serum creatinine: within normal limits. * a negative pregnancy test for all patients of childbearing potential. sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination * subject is capable to undergo the diagnostic investigations to be performed in the study * informed consent exclusion criteria: * any system therapy (chemo-/targeted therapy) * second, non-breast malignancy * active current autoimmune disease or history of autoimmune disease * active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. known hiv positive or chronically active hepatitis b or c * administration of other investigational medicinal product within 30 days of screening * ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's

Keywords: 99mtc-darping3 breast cancer metastatic lymph nodes her2
immunological characteristics of a population at risk of cholera after oral cholera vaccine (chovaxim)

Conditions: Diarrhea Infectious

Summary: the purpose of the study is to find out if individuals who received first and second dose of oral cholera vaccine (ocv) in lukanga swamps, central province of zambia have developed protection against future attacks to cholera. the investigators also want to investigate whether vitamin a deficiency and being hiv positive increases the chances of suffering from cholera.

cholera is caused by toxigenic strains of vibrio cholerae o1 and o139 and is characterised by sudden onset of acute watery diarrhoea that can lead to severe dehydration and ultimately death if not treated. zambia, has continued to experience cholera outbreaks in several parts of the country. in order to curb the disease outbreaks, the world health organisation (who) recommended introducing cholera vaccination as a supplementary cholera control measure together with other prevention and control strategies, in endemic areas as well as in other places at risk for cholera outbreaks. ocv has recently been introduced to zambia where a large population was vaccinated with 1 dose of shanchol®, and about 6 months later over 70% individuals traced to receive a second dose. considering the annual outbreaks of cholera in zambia, there is urgent need to determine whether shanchol® is able to elicit a sufficient and specific immunological response in individuals who received ocv in zambia. this study will also help the investigator understand whether there are immune response differences based on genetics and may indicate whether some people may need more vaccine regimens than others. objective 1: to profile cholera specific antibody status of a population at risk of cholera before and after receiving 1st and 2nd dose of shanchol ® oral cholera vaccine (ocv) objective 2: to profile and characterize cholera specific b and t lymphocyte phenotypes among the immunized zambians objective 3: develop and evaluate a non-invasive proxy measure of ocv immune responses objective 4: to measure the protective value of immunizing hiv-infected individuals through measurement of the neutralization capabilities ocv generated antibodies objective 5: to assess the impact of abo blood groups on cholera antibody generation

Eligibility criteria:
inclusion criteria: * participants aged 18-65 years are eligible to participate. * participant is a resident of the study area. residence was defined as individuals living in the study area for the past 1 year. * written consent provided by participant. exclusion criteria: * participant aged less than 18 years * refuses to consent to participate * pregnancy * participant has acute medical illness prior to receipt of oral cholera vaccine -participant has a history of hospitalization for cholera in the past one week

Keywords: diarrhea hiv vaccines
a clinical trial to compare efficacy and tolerability of fulvestrant 250mg, 250mg plus 250mg loading regimen and 500mg

Conditions: Advanced Breast Cancer; Metastatic Breast Cancer

Summary: this study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.


Eligibility criteria:
inclusion criteria: * breast cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor. * requiring hormonal treatment. * postmenopausal women (woman who has stopped having menstrual periods) exclusion criteria: * treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced bc. * treatment with more than one previous regimen of endocrine therapy for advanced bc. * an existing condition that prevents compliance.

Keywords: oncology cancer breast cancer
are double-ring wound-edge protectors effective for preventing superficial surgical site infection after open appendectomy?

Conditions: Acute Appendicitis; Surgical Site Infection

Summary: this study aims to evaluate the utility of double-ring wound-edge protectors to prevent the development of superficial surgical site infections after open appendectomy.

this is a multi-centric retrospective study comparing patients of similar characteristics with diagnosis of acute appendicitis that have been treated either by open appendectomy using a double-ring wound-edge protector or by laparoscopic appendectomy between january 2011 and december 2016 at hospital recoletas campo grande de valladolid and hospital comarcal de medina del campo. the main objective of the study is to compare the incidence of superficial surgical site infection in both groups. all patients included in the study must meet inclusion criteria and all data will be collected anonymously in order to comply with local law on personal data protection (organic law 15/1999 from 13 december about personal data protection). the authors of the study expect results of the study to be comparable with those in current literature regarding surgical site infections, hospital stay and procedure safety.

Eligibility criteria:
inclusion criteria: * age of at least 15 years old. * clinical diagnosis of acute appendicitis. * treated by: open appendectomy + double-ring wound-edge protector or laparoscopic appendectomy. * note: with the aim of avoiding selection bias, all patients presenting risk factors for surgical site infections (eg obesity, diabetes, malnourishment, immunosupression, etc.) will be included in the present study. exclusion criteria: * patients who did not receive prophylactic antibiotic. * source of abdominal pathology other than the caecal appendix. * follow-up period less than 30 days.

Keywords: acute appendicitis double-ring wound-edge protector superficial surgical site infection
comparison of effect on quality of recovery outcome between systemic lidocaine and dexamethasone in patients undergoing laparoscopic cholecystectomy

Conditions: Gallbladder Polyp; Asymptomatic Gallstones Without Cholecystitis

Summary: the primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy


Eligibility criteria:
inclusion criteria: * asa i-ii patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy due to gallbladder polyp or asymptomatic gallstones without cholecystitis exclusion criteria: 1. steroid therapy or immunocompromised patients 2. diabetes mellitus 3. allergy to lidocaine or dexamethasone 4. severe renal dysfunction (serum creatinine more than 1.6mg/dl) 5. severe liver disease ( liver enzymes more than two times normal values) 6. history of atrioventricular block 7. have a difficulty in understanding qor-40 (40-item quality-of-recovery scoring system) or korean language 8. history of physicologic disease

Keywords: dexamethasone lidocaine quality of recovery laparoscopic cholecystectomy
diet with or without metarecod® in obese subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: obesity is considered the largest chronic non-communicable disease (globesity) worldwide with a growing trend in the near future. weight loss programs are strongly recommended in obese patients, especially with type 1 diabetes mellitus (t2dm), although the majority of subjects do not reach or maintain the recommended weight loss target with nutritional intervention alone and one-third of those who achieve a significant weight loss returns to original body weight within one year. metarecod® (neopolicaptil gel retard) is a substance based medical device consisting of a macromolecule complex derived from high-fiber raw materials, whose mode of action consists in creating an endoluminal gel in the gut that limits glucose and lipids absorption. the primary aim of the present study is to assess whether the combination of metarecod® and standard diet as compared to diet alone can achieve a superior weight loss over 12 months of treatment. the present study will also compare the effects of the combination of metarecod® and diet vs diet alone on: 1. the improvement of glycemic variability and metabolic indexes; 2. the oxidative status, the endothelial anti-thrombotic activity, the inflammatory status; 3. the induction of favorable changes in gut microbiota composition and intestinal permeability.


Eligibility criteria:
inclusion criteria: 1. signed informed consent at study entry; 2. age: 30-70 years; 3. t2dm diagnosis according to the american diabetes association criteria since ≥6 months; 4. stable metabolic control as indicated by levels of glycated hemoglobin (hba1c) \<7.5% on two consecutive measurements before study enrollment; 5. body mass index (bmi) level ≥30 kg/m2 during the 3 months preceding randomization. exclusion criteria: 1. chronic treatment with corticosteroids and/or chronic treatment with non-steroidal inflammatory drugs, defined as ≥3 times/week with the rationale that these drugs independently impact on the whole inflammatory state; 2. clear indication for dual antiplatelet therapy and/or anticoagulant therapy (full dose); 3. active cancer or cancer in complete remission from less than one year, except for treated early-stage squamous or basal cell skin carcinomas; 4. for women with childbearing potential, pregnancy.
early ncpap before surfactant treatment in very preterm infants with rds

Conditions: Nasal Continuous Positive Airway Pressure,; Preterm Infants,; Surfactant Treatment,; Respiratory Distress Syndrome,; Bronchopulmonary Dysplasia

Summary: we hypothesis a period of early ncpap before surfactant treatment is effective for treating rds and preventing bpd in very premature infants.


Eligibility criteria:
inclusion criteria: * all enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early ncpap as the initial treatment exclusion criteria: * exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (prom) for \>3 weeks.
the wise (weightloss intervention surgical effects) brain study

Conditions: Diabetes; Weightloss

Summary: this study is being done to learn about the changes that weight loss causes on brain function, memory and thinking ability in adults. the study does not cover any costs associated with bariatric surgery.

there will be two groups of people studied: one group has chosen (independently of this research study) to have weight loss surgery to help them lose weight. another group will not choose to have any weight loss surgery. all research participants will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. they will have an mri brain scan at those same times also to look at changes in the structure and function of the brain tissue. blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.

Eligibility criteria:
inclusion criteria: * body mass index \>35 * diabetes or no diabetes * compatible with mri scanning * willing to give a small blood sample on 3 occasions * capable of providing informed consent exclusion criteria: * prior neurological disorder * mini mental status exam score * major psychiatric disturbance (schizophrenia, chronic intractable depression, * coronary revascularization, peripheral vascular disease * severe cardio vascular disease history * unstable medical conditions (cancer)

Keywords: weightloss and brain function effects of bariatric surgery on brain function reduced glucose insulin changes and brain function
randomized population-based study on chlamydia trachomatis screening

Conditions: Chlamydia Trachomatis; Infertility; Ectopic Pregnancy

Summary: 30,000 individuals living in aarhus county, denmark by oct 1997 were randomized into two groups. the intervention group received an invitation to be tested for urogenital chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). the control group received no intervention (21,000 individuals). outcome measures: number of tested individuals, number of detected infections, number of women developing pid, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving ivf treatment and number of men developing epididymitis. the hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.


Eligibility criteria:
inclusion criteria: * born in 1974, 1974 or 1976 and living in aarhus county october 1007 exclusion criteria: -

Keywords: mass screening
post abortion iud & recurrent abortion 2001-2004

Conditions: Abortion Rate

Summary: it has been shown that the immediate insertion of intrauterine devices (iuds) post-abortion prevents repeat abortions. the researchers hypothesize that providing free iuds post-abortion will be associated with a lower rate of repeat abortion in a canadian population. further, the researchers hypothesize that providing free iuds post-abortion will be associated with decreased costs for the health care system.

the researchers intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (iud) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. this data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free iuds post-abortion. the researchers will conduct a retrospective observational cohort study by chart review. the researchers propose to review the charts of 600 women undergoing abortions between january 1, 2001 and december 31, 2004 at kelowna general hospital's women's services clinic. the researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (ta), dates of subsequent tas, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of iud. the researchers will also record the recurrent pregnancy rates.

Eligibility criteria:
inclusion criteria: * female resident of interior health region seeking an abortion between january 1, 2001 and december 31, 2004 exclusion criteria: * women undergoing abortions for fetal genetic abnormalities

Keywords: abortion intrauterine device cost-effectiveness
spontaneous antigenemia in loiasis

Conditions: Loiasis; Lymphatic Filariasis

Summary: this prospective study will enroll and follow 60 loiasis patients with high worm burden to monitor the spontaneous release of filarial antigen in peripheral blood. this study will define the cross-reactive antigen profile of persons with spontaneous loiasis antigenemia, and determine whether it varies with time.

global efforts to eradicate lymphatic filariasis (lf) depend on rapid diagnostic tests (rdts) that detect wuchereria bancrofti circulating filarial antigen but these tests are unreliable in african nations where loa loa is co-endemic because they yield false-positive results in some individuals with loiasis. the goals of this project are to define the cross-reactive antigen profile of persons with spontaneous antigenemia, how it varies over time, and to determine which l. loa antigens in cross-reactive sera best distinguish loiasis cross-reactivity from lf. this prospective study will prospectively enroll 50 adults who presented with cross-reactive antigenemia at screening and 10 negative controls. participants will followed for one year and tested every three months for persistence of antigenemia.

Eligibility criteria:
inclusion criteria: * ability to give informed consent * loiasis mf count \> 20,000 mf/ml * resident of study area * no evidence of severe or systemic comorbidities * consent to storage of blood samples for future study exclusion criteria: * subject plans to move from the study area during subsequent 12 months

Keywords: diagnostics cross-reactivity